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Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy (Impel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03640000
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Information provided by (Responsible Party):
Hans Henrik Odland, Oslo University Hospital

Brief Summary:
This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy Not Applicable

Detailed Description:
Patients who are eligible for implantation af a Cardiac Resynchronization Therapy Device according to European Society of Cardiology guidelines are included. Measurements are performed on implanted leads and stored for post Processing. The study entry ends for each patient With completion of the implantation procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acute Changes in Bioimpedance During Cardia Resynchronization Therapy
Study Start Date : January 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Determination of impedance signals
This single arm study is designed to measure impedance signals from implanted leads in different positions in the heart. Signals obtained at different pre specified position are compared to each other to determine the robustness of the acquired measurements.
Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy
Bioimpedance measurements

Primary Outcome Measures :
  1. Optimization of Bioimpedance measurements [ Time Frame: 3 years ]
    Acquisition of absolute and imaginary bioimpedance signals from electrodes of known location within the heart at different input current frequencies. Pacing is performed from Three different electrodes during acquisition of bioimpedance acquisition forming Three different groups. Wavelets of the signals are analyzed within each Group and compared within the Group and between the Groups. Optimization is achived when a discrimination factor that is calculated is improved.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
- Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03640000

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Contact: Hans Henrik Odland, MD, PhD 23070000 ext +47

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Oslo University Hospital Recruiting
Oslo, Norway, 0027
Contact: Hans Henrik Odland   
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Hans Henrik Odland, MD, PhD Oslo University Hospital

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Responsible Party: Hans Henrik Odland, principal Investigator, Oslo University Hospital Identifier: NCT03640000     History of Changes
Other Study ID Numbers: 2014/1223
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases